Protocol Deviations/Exceptions from Research Reporting Requirements
General Information about Temple University IRB's
All research studies involving human subjects at Temple University requires Institutional Review Board (IRB) review and approval prior to implementation. The Institutional Review Board Adminsitrative Offices are located on the Health Science Campus at Temple University.
For Medical Intervention Studies the University has 3 Separate IRB Organizations listed on its Federal Wide Assurance (FWA00004964). (Memorandum about IRB Review Process). The IRB Organizations include Temple University IRB, Western IRB, and Fox Chase Cancer Center IRB. Each IRB is responsible for review, approval, and continuation of a project determined by the type of trial being proposed.
The IRB has crafted 5 primary YES/NO questions that assist investigators and staff determine which IRB Panel will review the project. (IRB Decision Tree Questions)
For Social and Behavioral Research Studies the IRB has a separate review panel and reviews are conducted on the main campus. The IRB Panel that reviews and approves the study is the IRB for the duration of the study conduct.
The Temple University Institutional Review Board is the primary point of contact for all Submission to any of the IRB's. This includes Initial Protocol Submissions, Interim Protocol Amendments, and/or Changes to the Proposed Research Plan. However each IRB has specific instructions and reporting requirements that are required to be followed prior to the panel's reviewing the information. It is the investigators responsibility to provide complete and accurate information to the IRB for each proposal.
This web-site is designed to assist Investigators and Staff Members with the required information and provides additional resources that assists with the application process. If you need assistance with navigating the IRB process please contact the Office of Clinical Trials Craig Pfister at 215 707-3106. If you have a specific questions regarding the type of IRB review required or about the IRB that will review your protocol, you can contact or the IRB Coordinator Richard Throm at 215 707-8757.
It is important to review the IRB Decision Tree Questions to determine the correct IRB panel that will review your protocol. It is also important to check the IRB Web-site for updated information or regarding the IRB Operations. The resources on this web-site were developed based on the Office of Clinical Trials experience in communicating with the IRB at Temple University.
Institutional Review Boards At Temple University (Home Page Access and Meeting Date Information)
It is important to always get updated information specific to conducting clinical research at the Temple IRB home page. The Temple IRB is responsible for review and approval of Biomedical and Behavioral Research conducted at Temple. The IRB Committee's are:
Medical Intervention Committees (A1 and A2) - Meeting Dates Generally the A1 Committee meets the 2nd Thursday of each month and the A2 Committee meets the 4th Friday of each month.
Grant Funded Research Studies - (i.e. NIH Awards, State, and Foundation awards)
Phase I and Phase II trials (including Industry Sponsored Research Trials)
Investigator - initiated Research Studies
Medical Device Research Studies
Behavioral and Social Committee (B Committee) - Generally meets the 3rd Friday of each month.
Complete and accurate materials are due to the IRB Office by 4:00 P.M. at least 2 weeks prior to the scheduled meeting date. Due to holiday's and other extenuated circumstances the meeting dates and submission dates may be amended. The IRB Chairman and Coordinator will coordinate the Meeting Agenda and confirm the protocol schedule for committee review. The number of protocols reviewed at each committee meeting varies, however their is a maximum number of protocols the committee can review as determined by the IRB Office. A target of 8-10 protocols is a general guidance for a regularly scheduled meeting, therefore it is encouraged to submit prior to the deadline. The IRB Chairman and Coordinator will handle any changes to the IRB shedule for protocol reviews.
Western Institutional Review Board (WIRB - Web Page) WIRB meets daily. The submission requirements are listed on Temple University IRB Decision Tree Page. Materials for review will be turned into the Temple IRB Coordinator. It is important that all communications occur with the Temple University IRB and not directly with Western IRB. The IRB Coordinator will ensure completeness and send the complete submission packet to Western IRB for review.
Industry Sponsored Phase III and Phase IV Multicenter Research Studies
The Fox Chase review is a 2 tiered process. The first review is completed by the Research Review Committee (RRC). The RRC generally meets every Wednesday to evaluate the scientific merit, general methodology, and statistical analysis of clinical research protocols. The second submission and review is the Fox Chase Institutional Review Board. When submitting to Fox Chase Institutional Review Board it is necessary to use their Submission Materials and Information including the HIPAA form.
Oncology Treatment Studies
All IRB Initial Protocol Submissions (Temple IRB, Western IRB, and Fox Chase IRB) must be submitted to:
Temple University Institutional Review Board
Attention: Richard Throm
3425 Carlisle Street
3rd Floor Hudson Building
Philadelphia, PA 19140
Level of Review
The Institutional Review Board (IRB) has the authority to approve, require modifications (to secure approval) or disapprove all research activities as directed by CFR 45 part 46 (policy 46.109 (a). The Chairman of the Institutional Review Board has final determination of the level of review that is required prior to the approval of the trial. The IRB Chairman will determine the level of review based upon the research proposal and level of risk associated with the trial. The review criteria are either Full Committee Review, Expedited Review, or Exempt from Review. The Principal Investigator shall contact the IRB Chairman to discuss Individual Protocols to finalize determination of review.
Full Committee Review
Medical Intervention and Social and Behavioral Trials that meet the definition of Clinical Research as detailed on the IRB Application Page. Full Committee reviews are typically required for Prospective Research Trials, but see the categories listed below (Expedited Review or Exempt from Review) for resesarch that may meet the criteria for a different level of review. IT IS IMPORTANT TO UNDERSTAND THAT ALL RESEARCH MUST BE REGISTERED WITH THE IRB.
Expedited Review
An expedited review procedure may be utilized by the IRB for certain kinds of research:
(1) involving no more than minimal risk to human subjects
Expedited Review Categories - Types of Projects that often qualify
Limited Blood Samples
Collection of Data by Non-invasive means
Non Invasive Collection of Specimens
Existing Materials (retrospective or prospective)
Voice/Video Recordings
No Investigational New Drug or Investigational New Device being used.
Group Characteristics
Criteria for Expedited Review
Procedures are Consistent with Good Research Design
Risks are Reasonable in relation to benefit
Research Participant Selection is equitable
Informed Consent is sought
There is a plan to collect and monitor data for participant safety
Privacy and Confidentiality is maintained
Additional Safeguards are required to protect vulnerable research participants
Submission requirements
Complete a full IRB Submission including all elements as required for a Full Committee Review. You will need to only provide the Original plus one copy of the IRB submission material to the IRB. The review is completed by the Institutional Review Board Chairman.
Demonstrate Proof Of Human Subject Protections Training and Certification as administered by the IRB
Submit Data Collection Forms or Additional Information as Available
Submit the Original Documents Plus 1 Copy to the IRB for review.
You must receive approval from the IRB prior to implementation. This review is completed by the Institutional Review Board Chairman or Designee
IRB Fee Schedule and Other University Critical Information
Fee Schedule
The Temple University IRB Fee Schedule is developed by the Office of the Vice President for Research and Graduate Studies. The Office of the Vice President for Research and Graduate Studies also handles the account reconciliation for the IRB as required. The IRB will assess review fee's to research sponsored by a for a for/profit entity. The fee's are generally assessed to Pharmaceutical, Biotechnology and Medical Device Companies Sponsoring research conducted at Temple University. Often times, the IRB staff does manage the invoicing and collection of IRB Fee's directly with the Sponsor of the Project. Therefore it is important to provide accurate billing information on the IRB Initial Review Form.
Institutional Review Board Addresses
The IRB that reviews and approves the trail should be listed on the FDA form 1572 for Investigational New Drug Studies. Only 1 IRB Should be listed.
Temple University Institutional Review Board
3400 N. Broad Street
Philadelphia, PA 19140
Western Institutional Review Board
3535 Seventh Avenue SW
Olympia WA 98502
Fox Chase Institutional Review Board
333 Cottman Avenue
Philadelphia, PA 19111
Other University Critical Information
Contract and Budget Information: For Industry Sponsored Trials
Primary Contact Person
Arleen Wallen, MS RD MBA
Temple University Office of Clinical Trials
3340 N. Broad Street-4th Floor SFU
Philadelphia, PA 19140
Phone: 215 707-9639
Fax: 215 707-8805
e-mail: arleen@temple.edu
Party to be listed on the Agreement:
Temple University of the Commonwealth System of Higher Education
Checks to be made payable to:
Temple University of the Commonwealth System of Higher Education
TU Representative Authorized to Sign Agreements:
Martin Dorph
Vice President and CFO/Treasurer
Tax ID#:
23-1365971
Where to Send Checks:
Temple University of the Commonwealth System of Higher Education
Health Science Center
Sponsored Projects Administration
3400 N. Broad Street
Philadelphia, PA 19140
ATTN: Dr. Kenneth Geller, PhD
